Associate CSR

Associate

• Lead the coordination, compilation, quality control, approval and post-approval processes associated with development of Pfizer global CSRs
• Create CSR mockups in System and populate document templates
• Project manage CSR compilation, approval and publishing activities
• Execute submission ready Quality Control (QC) on CSR components and structure
• Communicate with function lines regarding issues with CSR components and seek resolutions
• Seek approval from signatories on finalized CSRs and update clinical trial registry with CSR milestone status
• Prepare investigators declaration packages for distribution to the coordinating investigator
• Prepare study data packages required for distribution to study Principal Investigators (PIs)
• Coordinate Public Disclosure Synopsis (PDS) and Plain Language Summary (PLS) activities
• Publishes the approved report into Pfizer standard submiss...